First-in-class FDA approval for a new drug class

Bristol Myers Squibb secured the first-in-class FDA nod for Zenbexus, its protein degrader in multiple myeloma. The approval positions CELMoDs (covalent and targeted protein degraders) as a successor pathway to BMS’s legacy myeloma treatments. The company is framing Zenbexus as an advance in the next generation of targeted cancer medicines, with regulatory clearance effectively validating the CELMoD mechanism in patients. BMS’s commercial strategy will hinge on how Zenbexus integrates into existing regimens and where label expansion follows the initial approval.